Description

Tafamidis Meglumine is a high-purity pharmaceutical salt form of the transthyretin (TTR) stabilizer tafamidis, specifically designed for enhanced solubility and bioavailability. This compound is critical for the formulation of life-changing therapies targeting transthyretin amyloidosis (ATTR), a progressive and fatal disease. It is essential for pharmaceutical manufacturers and advanced research institutions developing and producing innovative treatments for cardiac and neurological ATTR.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of oral medications treating transthyretin amyloid cardiomyopathy (ATTR-CM).
• Key Intermediate in the synthesis and final formulation of tafamidis-based therapies under Good Manufacturing Practice (GMP) conditions.
• Pharmaceutical Research & Development for studying TTR stabilization mechanisms and developing next-generation amyloidosis treatments.
• Reference Standard in analytical laboratories for quality control, method validation, and regulatory compliance testing.
• Clinical Trial Material supply for ongoing studies exploring new indications or combination therapies for ATTR.
• Formulation Development for creating patient-centric dosage forms with optimized stability and pharmacokinetic profiles.

Basic Information

Product Name	Tafamidis Meglumine
CAS No.	951395-08-7
Molecular Formula	C14H7F6NO4 • C7H17NO5
Molecular Weight	503.39 (Free acid) + 195.21 (Meglumine) = 698.60 g/mol
Synonyms	2-(3,5-Dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid compound with 1-deoxy-1-(methylamino)-D-glucitol (1:1); Tafamidis Meglumine Salt; Tafamidis meglumine; Vyndaqel API; TTR Stabilizer Meglumine Salt; Fx-1006A; AG10 Meglumine; Transthyretin Stabilizer
EINECS	Contact for details

Quality Control

Our Tafamidis Meglumine is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols align with ICH guidelines, ensuring identity, purity, strength, and composition. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for assay, related substances, residual solvents, and microbiological attributes. We support regulatory filings with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccated environment after opening to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.